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MediQuest Therapeutics Persuades FDA to Do 6-Month Review of Lead Product

The FDA gave MediQuest Therapeutics a boost today. MediQuest, the developer of a treatment for Raynaud’s disease, a painful condition of the hands and feet, said the FDA has agreed to give its drug application an expedited 6-month review since it can treat an unmet medical need. The agency usually takes 10 months to consider an application, particularly if it’s the fourth or fifth in a class of well-known drugs, like statins for lowering cholesterol.

MediQuest, a privately-held company in Bothell, WA, turned in its application to U.S. drug regulators in April. That means the firm may learn as soon as October whether it can make the leap from being solely a developer of new drugs to being a company that also has a product to sell. If approved, the drug would also be the first product specifically for Raynaud’s.

The drug (formerly dubbed Vascana in company statements, now being called MQX-503), is a topical formulation that patients can rub on their hands or feet to prevent or treat the symptoms of a painful Raynaud’s flare-up. About 2.1 million people are estimated to have sought medical treatment for the disease, and about 90 percent are women, MediQuest has said. How many of them may seek out MediQuest’s therapy is the burning question.